NCT07125027 A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
| NCT ID | NCT07125027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Natural Medicine |
| Condition | Lumbosacral Radiculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes. The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews. The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
Eligibility Criteria
Inclusion Criteria: * ● Adults age 18-65 years at the time of enrollment * Ability to stand for 10 minutes * Presence of lumbosacral radicular pain within the past week that extends below the knee (i.e., pain radiating from the low back into the leg in a nerve root distribution) with or without accompanying low back pain, of at least 12 weeks' duration, AND * Tampa Scale of Kinesiophobia score ≥ 23 * At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following: * Positive straight leg raise test (eliciting radicular pain below the knee at ≤70 degrees of elevation); * Positive Valsalva maneuver (eliciting radiculcar pain below the knee); * Positive slump test; * Neurological deficit in a lumbar nerve root distribution, including at least one of the following: * Dermatomal sensory loss, * Myotomal weakness, or * Reduced or absent deep tendon reflexes (e.g., patellar or Achilles reflex) corresponding to the affected